– By Ashish Gosain
– The Author is an Intellectual Property and Legal practitioner and a PhD scholar in Science Policy at Jawaharlal Nehru University, New-Delhi.
Ever since the impetus on economic globalization began, a key aspect of the Trade and Technology debate has been the creation of capabilities in domestic Industry, to enable them to compete in the International markets, while responding to the needs of their domestic constituency and society. This is markedly the case in the Pharmaceuticals Industry. The need of enabling technology-oriented growth requires the critical mass of Learning opportunities. This has to be aligned with the redistributive goals of access to medicines in a developing country context.
As the global integration of economies continues and increases in foreign FDI flows is touted to be the next big thing, there emerges tensions between the processes of internationalization on the one hand and maximizing welfare in society on the other. The primary burden on domestic Institutions in this context, thus need not be over-emphasised. It is here the role of multilateral institutions has come under sharp focus in export-oriented economies like that of India. In the post TRIPS era, countries are grappling with the failed promise of multilateral institutions, in terms of redistributive justice. Today, as the World confronts the worst pandemic in a hundred years, the situation has brought to centre stage, certain priorities that seek to re-emphasize the notion of regulatory sovereignty.
The particular context is that of the policy space that countries have in relation to recalibrating the structural nature of developing economies to enhance developmental outcomes from Trade in Technology. As the pressures on Domestic healthcare systems brings them to brink of collapse, the need for supportive institutions that heal the world onto path out of this pandemic are crucial. In a previous conceptualization, Healthcare in resource constrained settings was forced to focus on provisioning of Infrastructure under a Public Goods paradigm. This is more so today, in view of Healthcare 4.0, where the focus shifts to generation of patient outcomes. One such institution is the promotion of Innovation that brings the competing mandates of social welfare provisioning and providing long-term incentives for innovation. Strengthened Intellectual Property protection in terms of TRIPS plus standards is having a negative impact on affordability and accessibility of medicines. Thus, calls for serious and collective efforts at reform is the need of the Hour. This increasing property rights protection, coupled with the lack of R & D productivity by vertically integrated firms (Ippoliti et al, 2019) for treatment in areas of disease burden, coupled with an inability to learn from past experience are making the current situation more and more difficult. The need to adopt a humanitarian approach to the pandemic and the challenges that it poses will serve to reinstate some of the faith that Nations have in the ability of international Institutions to moderate trade and economic imperatives with needs of society.
The flexibilities in the TRIPS framework (Trade related Intellectual Property Rights) have retained welfarist objectives after a hard-fought battle by civil society, activists, international organisations etc. The developments that lead to the Doha Ministerial Declaration had breathed life into the prospect of access to medicines. However, in the successive decades since, the momentum on access to medicines has suffered numerous setbacks. While the problems associated with proprietary regimes with public health emergencies has been a consistent theme, the continuing review of it’s alignment with developmental priorities is in question. The trend of hedonistic regionalism that has been spawned in the last decade is a retreat from the initial promise of globalization. Today, with the trends of “Vaccine Nationalism” being seen, which is in violation of jus cogens, a cardinal principle of International Law, Nations scurry to stockpile reserves, impose newer restrictions on international migration and impose trade curbs on exports, through emergency measures justified under Domestic Laws. This coupled with the regulatory capitalism imposed on countries, in the name of incentives of innovation has to take a view at the Internalisation dimension in the Ownership Location and Internalisation Paradigm. If there is anything in the name of international solidarity, in humanity’s darkest hour, Developed countries should part with control over resources needed to enable the World to overcome this crisis.
For this to happen, the leadership must come from multilateral Institutions, which have hitherto faced a democratic deficit, in regard to their assumption of an agenda setting role. The disappointment over the functioning of the World Health Organization in facilitating soft Law approaches towards domestic Disease surveillance has come under severe criticism, since the outbreak of the CoVID-19 virus. This is on account of the underlying institutions that enable trade in technology in this Sector. Secondly, while there has been a mobilization of actors of various types in enabling domestic Innovation systems, yet the regulatory spillovers sustaining this process of technology led growth must not loose sight of the structural features of the economic structure of countries , coupled with their developmental status. A key question arises in relation to the structural resilience of Innovation value chains supporting Healthcare as a Sustainable Development Goal. The transition period given to Less developed countries should be enhanced so as to facilitate domestic capacity building under non-proprietary regimes of Intellectual Property. For other transition economies, actuating the critical mass of learning opportunities from global participation must be done (Pietrobelli and Rabelloti, 2009). All in all, the real promise of globalization lies in generating the structures that facilitate and promote greater cohesion and international collaboration among a diversity of actors to promote healthcare provisioning in the World on a long-term basis.
References
- Foreign Direct Investment inflows into Pharmaceuticals sector in the period April 2020- December, 2020 was 9234 crore rupees (USD 1246 Million); In April 2019 – March 2020 was 3650 crore rupees (USD 518 Million) and 1842 crore rupees (USD 266 Million) in FY 2018-19. (Source: Minister of State for Shipping and Chemicals and Fertiliser’s Reply to Parliament). For recent policy movements see Kirtika Suneja, “Mega FDI plan to focus on faster pharma approvals”, Economic Times (10th May, 2020)Online at: https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/mega-fdi-plan-to-focus-on-faster-pharma-approvals/articleshow/75664593.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst.
- Declaration on Patent Protection-Regulatory Sovereignty under TRIPS agreement, available online at : https://www.mpg.de/8133454/Patent-Declaration1.pdf . The author participated in a workshop on the Deliberations of the Declaration held in New Delhi during 2017.
- Mohammed El Said, “Radical Approaches during Unusual Circumstances: Intellectual Property regulation and the CoVID -19 Dilemma,” Development, DOI: 10.1057/s41301-020-00257-x
- Roberto Ippoliti et al, “Partnership and Innovation in the Pharmaceutical Industry: the case of clinical research”, Economics of Innovation and New Technology”, DOI: 10.1080/10438599.2019.1701782.
- The Year 2020 marked the 18th Anniversary of the Doha Ministerial Declaration on Trips agreement and Public Health.
- “Foreign Direct Investment: The OLI framework”, University of Oxford, available online at : http://users.ox.ac.uk/~econ0211/papers/pdf/fdiprinceton.pdf . One of it’s key proponents, John Dunning viewed knowledge as “Ownership advantages”.
- Carlo Pietrobelli et al (2007), “ Global Value Chains and Technological Capabilities: A Framework to Study Industrial Innovation in Developing Countries” , DOI: 10.4324/9780203937396.ch6 .
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